Brazilian regulator says Bharat Biotech’s Covaxin manufacturing facility fails to meet CGMP standards

By: |
March 31, 2021 4:40 PM

Bharat Biotech International Limited on February 26 said it has signed an agreement with the Brazilian government for supply of 20 million doses of Covaxin during the second and third quarters of the current year.

Covaxin has demonstrated an interim vaccine efficacy of 81 per cent in the Phase 3 clinical trials.

The Brazilian health regulator Anvisa has denied permission to import Bharat Biotech’s COVID-19 vaccine Covaxin into the country after its authorities found that the plant in which the vaccine is being made did not meet the Current Good Manufacturing Practice (CGMP) requirements.

Reacting to it, the city-based vaccine maker said it is working towards resolving the issues cited during the inspection and the order of 20 million doses from the Brazilian government is still active.

National Health Surveillance Agency Anvisa in its website said it received a request from the Brazilian Health Ministry to import 20 million doses of Covaxin.

However a decision on that was suspended by the regulator due to the absence of some key documents.

“…considering the non-compliance with the requirements of Good Manufacturing Practices for Medicines, or the non-compliance with the petition procedures submitted for analysis, advocatedby current legislation,resolves: Refuse the Request (s) for Certification of Good Manufacturing Practices for Medicines of the company (ies) contained in the ANNEX,” a Brazilian government gazette said on March29.

Bharat Biotech in an email reply did not comment on the CGMP issues. Bharat Biotech International Limited on February 26 said it has signed an agreement with the Brazilian government for supply of 20 million doses of Covaxin during the second and third quarters of the current year.

The company had earlier said it also signed an agreement with Brazil-based Precisa Medicamentos for the supplies ofCovaxin for the private markets in the South American country.

“The requirements pointed out during inspection will be fulfilled, the timelines for fulfillment is under discussion with the Brazil NRA and will be resolved soon,” the company told PTI in an email reply.

The agreement with Precisa Medicamentos is based on a long term partnershipand will continue, Bharat Biotech said.

To another query, the vaccine maker said it has submitted for EUA’s (emergency use authorisation) in more than 40 countries and several countries have already issued the authorisation and supplies are in process.

Covaxin has demonstrated an interim vaccine efficacy of 81 per cent in the Phase 3 clinical trials.

The trials involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research, the city-based-based company had earlier said in a statement.

Get live Stock Prices from BSE, NSE, US Market and latest NAV, portfolio of Mutual Funds, Check out latest IPO News, Best Performing IPOs, calculate your tax by Income Tax Calculator, know market’s Top Gainers, Top Losers & Best Equity Funds. Like us on Facebook and follow us on Twitter.

Financial Express is now on Telegram. Click here to join our channel and stay updated with the latest Biz news and updates.

Next Stories
1Lockdown should be last resort: PM Modi
2Govt aid will help vaccine production, says Poonawalla
3Vaccine ramp-up: Advance of Rs 4,500 crore to be paid to SII, Bharat Biotech